Biophysics for Therapeutic Protein Development / edited by Linda O. Narhi.

Format:

Book

Contributor:

Narhi, Linda O., editor.

SpringerLink (Online service)

Series:

Biomedical and Life Sciences (Springer-11642)

Biophysics for the life sciences ; 4.

Biophysics for the Life Sciences ; 4

Language:

English

Subjects (All):

Pharmacology.

Clinical biochemistry.

Proteins.

Biophysics.

Pharmacology/Toxicology.

Medical Biochemistry.

Protein Science.

Protein-Ligand Interactions.

Biological and Medical Physics, Biophysics.

Local Subjects:

Pharmacology/Toxicology.

Medical Biochemistry.

Protein Science.

Protein-Ligand Interactions.

Biological and Medical Physics, Biophysics.

Physical Description:

1 online resource (IX, 293 pages) : 73 illustrations, 31 illustrations in color.

Edition:

First edition 2013.

Contained In:

Springer eBooks

Place of Publication:

New York, NY : Springer New York : Imprint: Springer, 2013.

System Details:

text file PDF

Summary:

The last few decades have seen the genesis of protein therapeutics, such that these large molecule based drugs comprise an increasingly larger part of the commercial market. The conformation (overall global fold or three-dimensional structure) of these molecules is important for maintaining biological activity, stability during long term storage, and can impact the safety profile and biological consequences of administration. For this reason at every stage of product discovery and development biophysical methods play a key analytical role in product development, as they are applied for the determination of protein higher order structure. In addition to helping define binding kinetics and other parameters important for target validation, they are the only techniques available to determine if a potential protein product is folded properly, and can maintain this active conformation during manufacturing, storage, and delivery. Thus the biophysical techniques play a key role during the development of protein therapeutics. This volume is organized to mimic the product lifecycle. The initial chapters describe the underlying theory, and strengths and weaknesses of the different techniques commonly used during therapeutic development. The majority of the chapters discuss the applications of these techniques, including case studies, across the product lifecycle from early discovery, where the focus is on identifying targets, and screening for potential drug product candidates, through expression and purification, large scale production, formulation development, lot-to-lot comparability studies, and commercial support including investigations. There is also a chapter from the perspective of the regulatory agencies. This book can be used to provide insight into this important application of biophysics for those who are planning a career in protein therapeutic development, and for those outside this area who are interested in understanding it better. y>.

Contents:

Introduction

High Throughput Biophysical Approaches to Therapeutic Protein Development

Techniques for Higher Order Structure Determination

Biophysical Techniques for Protein Size Distribution Analysis

Qualification of biophysical methods for the analysis of protein therapeutics

Application of Biophysics to the Early Developability Assessment of Therapeutic Candidates and its Application to Enhance Developability Properties

Application of Biophysics in Formulation, Process and Product Characterization: Selected Case Studies

Biophysical Analysis in Support of Development of Protein Pharmaceuticals

Case Studies Applying Biophysical Techniques to Better Characterize Protein Aggregates and Particulates of Varying Size

Investigation of Non Conformance During Protein Therapeutic Manufacturing

Higher order structure and protein aggregate characterization of protein therapeutics: perspectives from good manufacturing practices and regulatory guidance

Index.

Other Format:

Printed edition:

ISBN:

978-1-4614-4316-2

9781461443162

Access Restriction:

Restricted for use by site license.